Treatment of orthopedic tissue

ABSTRACT

The disclosed system includes a probe for mechanically cutting tissue Other components of the system include a luminally protective sheath, a microscopic end cauterizing probe, a surgical console, an identification-sensitive self-sealed cassette, and a plurality of flexible tubing lines with pinch valves thereon.

RELATED APPLICATION INFORMATION

This patent is a continuation of application Ser. No. 15/486,101 filedApr. 12, 2017, now U.S. Pat. No. 9,968,371, which is acontinuation-in-part of application Ser. No. 15/389,250 filed Dec. 22,2016, now U.S. Pat. No. 9,675,373, which is a continuation ofapplication Ser. No. 13/344,872 filed Jan. 6, 2012, now U.S. Pat. No.9,549,751, which is a continuation-in-part of application Ser. No.12/430,532 filed Apr. 27, 2009, now U.S. Pat. No. 8,603,123, whichclaims priority to provisional patent applications: Application No.61/048,427 filed Apr. 28, 2008, Application No. 61/104,382 filed Oct.10, 2008, Application No. 61/120,115 filed Dec. 5, 2008, and ApplicationNo. 61/086,775 filed Aug. 6, 2008, all of which are incorporated hereinby reference.

Other related applications: application Ser. No. 13/344,901 filed Jan.6, 2012, now U.S. Pat. No. 9,039,719.

NOTICE OF COPYRIGHTS AND TRADE DRESS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. This patent document may showand/or describe matter which is or may become trade dress of the owner.The copyright and trade dress owner has no objection to the facsimilereproduction by anyone of the patent disclosure as it appears in thePatent and Trademark Office patent files or records, but otherwisereserves all copyright and trade dress rights whatsoever.

BACKGROUND Field

This disclosure relates to treatment of orthopedic tissue.

Description of the Related Art

The prostate is a walnut-sized gland located beneath the bladder and infront of the rectum. The urethra passes through the prostate to thebladder neck. Commonly, as a man ages, the prostate begins to grow andthis growth often results in the prostate squeezing the urethra withinit. This proliferation of tissue in the prostate gland is known asbenign prostatic hyperplasia (BPH). BPH causes urination problems whenan enlarged prostate presses against the urethra narrowing the canal.BPH is estimated to affect over fifty percent of men over the age ofsixty.

Approximately one-third of prostate tissue is anterior to the urethraand consists of fibromuscular tissue physiologically related to theurethra and bladder. Approximately two-thirds of prostate tissue isposterior to the urethra and consists of glandular tissue. BPH involvesbilateral nodular expansion of prostate tissue in a transition zonebetween the fibromuscular tissue and the glandular tissue. Withouttreatment, BPH obstructs the urethra to cause a slow or interruptedurinary stream, nocturia, increased frequency of urination, a sense ofurinary urgency, and incontinence. Occasionally, BPH is also responsiblefor more severe problems including uraemia, hydronephrosis, and urinarytract infections. Uraemia is retention in the bloodstream of wasteproducts normally excreted in the urine. Hydronephrosis is the dilationof the branches of the pelvic cavity and the kidney, caused by anaccumulation of urine resulting from obstruction of normal outflow.

Systems and methods exist to treat BPH. These include drug therapy,non-surgical procedures, and surgical procedures (i.e., prostatectomy).

Drugs often have side effects and must be taken long-term for continuedeffectiveness.

Non-surgical (without mechanical cutting) conventional BPH procedures,such as thermotherapy, use various forms of energy (radiofrequency,microwave, ultrasound, etc.) to ablate the prostate tissue. Theapplication of energy is usually overbroad and results inablation-induced collateral damage and necrosis (cell death) of healthyurethral tissue. These non-mechanical energy delivery devices alleviatesymptomatic pressure and widen the constricted urethra by coring out anew urethral channel formed by scar tissue. However, overly aggressivescar tissue proliferation occasionally results in some individuals, andcan have side effects including seminal vesicle blockage (leading toreverse ejaculation, dry climax, etc.) and an increase in volume thatcreates pressure and undermines the achievement of volume reduction inthe prostate. Other technologies such as TURP (TransUrethral Resectionof the Prostate) and LASER (Light Amplification by Stimulated Emissionof Radiation) also destroy healthy tissue including important muscles atthe bladder neck. The bladder neck is a common target for treatment. Thewidening with both TURP and LASER damage the bladder's muscularstructure that can lead to bladder incontinence and can also reduce oreliminate the bladder neck's ability to constrict upon sexualstimulation/ejaculation allowing the ejaculate to travel in reverse intothe male's bladder, thus yielding him with reverse ejaculation.

Conventional surgical systems for removal of the prostate(prostatectomy) are bulky and expensive and their use generally resultsin the loss of fertility. Prostatectomy is typically performed as anin-patient procedure requiring general anesthesia, a longer termhospital stay, and a significant recovery time before a patient returnsto work.

Thus, the common approaches to BPH treatment are not minimally invasiveand result in trauma to and the removal of the urethral lining, crucialbladder neck musculature, and the prostate's capsule, as well as anunnecessarily large section of the prostate or the entire prostate.Common approaches damage the urethra which results in scar tissue thatmay occlude the seminal vesicle with the reduction or potential loss offertility and possibly increase the potential for reverse ejaculation,resulting from the blockage and reduced smooth lining of a naturalurethra. Damage to the smooth lining of the urethra caused by theseapproaches results in increased pain, discomfort, extendedcatheterization, additional time off from work (recovery), increaseddependence on pain medications and extended (and expensive) in-patienthospital stays.

Recent prostate treatment probes have focused on newer energy therapieswhile an understanding of how to precisely control them to selectivelyremove tissue remains to be mastered. Mechanical cutting/coring ofprostate tissue has remained largely unconsidered.

Another important consideration in BPH treatment is to address theproblem early. This is in contrast to the “watchful waiting” approachthat typically coincides with drug therapy while putting off surgeryuntil symptoms become unbearable and conclusively demonstrateirresponsiveness to drugs. The easier and safer the surgical procedurebecomes the less it is something to be put off and avoided. There aresignificant benefits to be obtained in early intervention in the form ofpreserved bladder muscle tone and function. The longer an individualwith a developing hypertrophic prostate waits before having surgery (toremove the hypertrophic portion) the more likely it is the hypertrophictissue will begin to obstruct the bladder neck which leads to all sortsof complications as the bladder reacts to try and achieve a higherpressure to pass fluid through the constricted neck. These complicationsinclude: permanent loss of detrusor contractile ability, involuntarydetrusor contractions, partial denervation of the bladder smooth muscle,bladder irritability and instability, early termination of voiding,intermittency of the urinary stream, higher residual urine volume, lossof bladder compliance, and overall bladder mass increase with lessmuscle tone and more collagen deposition. As the body reacts to theobstruction the internal and external sphincters can also be damaged andworn down. The loss of involuntary muscle response that accompaniesdamage to the internal sphincter generally cannot be reacquired throughtraining (whereas training is sometimes effective to reverse damage tovoluntary muscles). Thus, damage to the internal sphincter from waitingtoo long for surgery and/or from other less selective procedures cancause irreversible reverse ejaculation.

DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a mechanical coring atherectomy probe from the proximaltowards the distal end.

FIG. 2 shows a vertical cross-sectional view through the coring probe ofFIG. 1 illustrating the four functional pipes, each for performing adifferent function, and how the top of the instrument may be tapered forimproved ergonomic handling.

FIG. 3 shows a horizontal cross-sectional view along the longitudinalcentral axis of the probe from the left side illustrating how variouselements including the functional pipes, the light cone, and the springand piston actuation mechanism fit together compactly within theproximal shaft and handpiece.

FIG. 4 shows a similar horizontal cross-sectional view as in FIG. 3 butlooking from the right side and better illustrating how the two centralpipes, the aspiration pipe above and the power supply pipe below,connect with the piston actuation mechanism.

FIG. 5 shows another horizontal cross-sectional view along thelongitudinal central axis in which the instrument has been turnedapproximately 90 degrees from the view in FIG. 3 or FIG. 4 to fully showthe spring and piston from bottom to top with the power supply pipeobscuring the aspiration pipe at the proximal end.

FIG. 6 highlights a select group of internal components without theouter handpiece as viewed from the proximal to the distal end, clearlyshowing the piston and spring actuation mechanism with the aspirationpipe passing through it, the fiber optic cable on the outside, and thebase of the light cone with its connection port for the infusion pipe(not shown).

FIG. 7 highlights just the spring and piston, turned 90 degrees from inFIG. 6, with the aspiration pipe geared to the piston such thatactuation of the piston through the lower stroke stop and spring drivesthe aspiration pipe and the cutter (not shown) at its distal end.

FIG. 8 shows the distal cutting end of the mechanical coring atherectomyprobe with the blade housed within the dome-shaped hood and the portsthrough the light sheath and its opaque shrink-wrapped cover to vent theinfusate.

FIG. 9 shows the distal cutting end of the probe, as in FIG. 8, fromanother perspective better illustrating how the blade fits within thedomed hood and how the lens portion at the distal end of the instrumenttapers slightly approaching the hood.

FIG. 10 shows a cross-section cutout view of the distal end of theinstrument highlighting how the domed hood fits within the light sheathand how the blade (with a portion chopped off) fits within the domedhood with the shape of the blade complementing the geometry of the hood.

FIG. 11 shows only the blade, according to one embodiment in which it isan arch, connected to its cylindrical shaft which becomes the aspirationpipe at its proximal end and passes through and is geared to the pistonfor actuation to drive the blade's motion.

FIG. 12 shows only the domed hood or cover for the blade with variousopenings/portals/windows therein through which the blade interacts withand severs tissue.

FIG. 13 shows a cross-section through the light cone, with the fiberoptic cable or other visualization means leading into it on the rightside, and the covered light sheath with extruded grooves therein (forconveying infusant) leading out of its tapered tip at the upper left.

FIG. 14 shows the light sheath with extruded grooves therein forconveying infusant and a thin opaque cover on its outside for preventingthe escape of light.

FIG. 15 shows a close-up view of how a central chamber within the lightcone is feed by an infusion port at the lower right and in turn feedsthe covered light sheath at the upper left.

FIG. 16 shows how the light sheath with extruded grooves therein conveysinfusate all the way to the distal tip of the instrument with the lightsheath turning into a lens at its distal tip and tightly wrapped with athin opaque cover with venting ports for aerating the infusate passingthrough both the light sheath and opaque cover.

FIG. 17 is a side view of the pertinent anatomy.

FIG. 18 is a side view of an access tool being inserted into theprostate.

FIG. 19 is a side view of a coring probe for tissue removal beinginserted into the prostate with the guidance of a template or grid.

FIG. 20 is a side view showing cavities where core prostate tissue hasbeen removed and a device being inserted to ensure hemostasis.

FIG. 21A is a perspective view of a protective delivery sheath.

FIG. 21B is a perspective view of an insertion device for the protectivedelivery sheath.

FIG. 22 is a perspective view of an inflation device for inflating theprotective delivery sheath which is shown over the insertion device.

FIG. 23 is a limited view showing the protective delivery sheath beinginserted up the urethral canal and sealants in place within the cavitieswhere core tissue has been removed for ensuring hemostasis.

FIG. 24 is a limited view showing the protective delivery sheathinserted farther up into the urethral canal after inflation.

FIG. 25 is a limited view showing a deflated tamponading balloon beingdelivered up the urethral canal through the protective delivery sheath.

FIG. 26A is a limited view showing a first deflated tamponading balloonin the seminal vesicle and a second deflated tamponading balloon in theurethral canal.

FIG. 26B is a side view of the dual balloon inflation device thatinflates the tamponading balloons with a unit dose of refrigeratedsaline.

FIG. 27 is a limited view showing the inflated tamponading balloons inposition with one balloon in the urethral canal and the other balloon inthe seminal vesicle, to apply pressure to the cored prostate forhemostasis while enlarging the urethral canal and the seminal vesicle.

FIG. 28 is a limited view showing the enlarged urethral canal andseminal vesicle after the tamponading balloons have been deflated andremoved.

FIG. 29 is a front view of the surgical console withidentification-sensitive self-sealed cassette, foot pedal to controlaspiration, and tubing lines with pinch valves thereon.

DETAILED DESCRIPTION

The probe disclosed herein may be used to remove tissue to prevent,eliminate, reduce or reverse obstruction of the bladder neck andpreserve the natural bladder and sphincter health, muscle tone, andstability to avoid this cascade of potentially irreversible events. Thecoring atherectomy probe and system may also find advantageousapplications in regions of the body outside the prostate and forindications other than amelioration of BPH. For example, the mechanicalcutters of the coring probe may be useful in an array of orthopedicprocedures for such tasks as tissue shaving, debridement, and boneresurfacing. Live aspiration can be useful to immediately suction outparticulate bone fragments as bone is cut. The types of orthopedicprocedures in which the probe can be used include but are not limitedto: hip replacements, knee surgeries, shoulder surgeries, etc.

The probe is designed to de-bulk by removing the core prostate tissuethat is most proximal to the bladder neck in order to maintain thebladder neck's natural ability to contract. The mechanical cutting probedescribed herein may achieve this since it does not cause thepost-removal scar tissue associated with laser, transurethral incisionof the prostate (TUIP), and TURP procedures. Scar tissue canenlarge/swell and re-clog the bladder neck to undo the benefits of TURPor LASER procedures. Scar tissue around the seminal vesicle, and thedamaged bladder musculature, can be responsible for reverse ejaculation.The amount of post-procedure scar tissue through a low trauma selectivemechanical cutting approach drastically reduces the potential forreverse ejaculation and post-treatment restenosis and the impact theseevents can have on quality of life, sexual function, and self-esteem.

The devices and methods disclosed herein provide for immediate removalof bulk core prostatic tissue to provide instantaneous relief of BPH.This technology also allows core bulk tissue removal at the bladder neckwhile our system does not target or damage the bladder neck's muscularstructure. This will reduce or eliminate reverse ejaculation when usedas indicated.

The systems disclosed herein may eliminate the need for a catheter anddo not use heat to destroy the urethral lining, excess tissue, ormalignant tissue. In accordance with principles disclosed herein if acoolant fluid is used it is within a balloon rather than a catheterchamber. The systems disclosed herein are more efficient thancontemporary systems and methods because they use a device to preciselycut and remove bulk tissue via mechanical coring rather than heat todestroy tissue. Therefore, the coolant does not interfere with tissuedestruction by coring whereas a coolant would work against and becounter-productive to treatment by heating.

The mechanical coring probe disclosed herein may be insertedtransperineally or transurethrally with or without the assistance of thetransurethral protective delivery sheaths and access systems as arerespectively disclosed in commonly owned application Ser. No. 61/048,427and Ser. No. 61/086,775. To the extent that they are not inconsistentwith the present application, Application Ser. No. 61/048,427 and Ser.No. 61/086,775 are incorporated by reference.

The disclosed devices may be used with dilators to create the workingspace. However, this is not essential and these dilators need not beballoon dilators but can include other means such as dilating trocarswith progressively increasing diameters.

The disclosed probes may be minimally invasive and preserve the surroundtissue (e.g., urethral lining and prostatic capsule) by, at most, onlymaking a very small self-sealing “micro puncture” at an entry point. Forexample, a self-sealing micro puncture is only created to the prostaticcapsule and the urethral lining is left pristine for reduced pain,discomfort, and normal urinal flow patterns post the core bulk tissueremoval procedure. The micro puncture of the prostatic capsule is uniqueto access the core of the prostatic lobes with the atherectomy systembut also to control bleeding by maintaining an enclosed environmentwhich will self-seal if the micro puncture is maintained during theprocedure. The probe is delivered directly to the target area of thebulk core prostatic tissue that is to be removed to alleviate thesymptoms of BPH.

Using the disclosed devices, it is possible for cutting to occur whilethe lumen (or window through which tissue enters/exits is) is stillopen, at least in part.

As disclosed herein, for prostate treatment only excess core prostatetissue or malignant tissue is selectively eliminated and the entiregland need not be removed. The disclosed devices do not deliver tissuedestroying heat to the urethral lining, and are focused on preservingthe urethra and prostatic capsule rather than cauterizing it asdisclosed in reference art methods. Also with the disclosed devices theblade can move faster, i.e., higher cuts per minute (CPM) since it doesnot have to wait for heat transfer as its sharp edge alone severs tissueon impact. The disclosed methods and systems focus on removing coreprostatic tissue rather than urethral tissue and include several othercombinations of simultaneous therapies (including auxiliary drugs,lasers, microwaves, ultrasound, radio waves, etc.) that may optionallybe incorporated to supplement the main treatment via mechanical coringbut are not necessary for effective treatment.

The disclosed systems and methods provide surgical instruments formechanically cutting/coring excess or diseased tissue from the core ofthe prostate gland. The devices, systems, and methods described hereinmay be applied to treat prostate cancer, to ameliorate the condition ofbenign prostatic hyperplasia (BPH), or for other purposes. Theembodiments described herein may be applied to relieve impingement ofthe prostate gland on the urethral canal and the bladder neck whilemaintaining the smooth natural linings of the urethral and seminalvesicle lumens. The probe was also described in co-pending commonlyowned provisional application Ser. No. 61/104,382 entitled “Mechanicalcoring prostatic atherectomy probe with live aspiration” filed Apr. 28,2008 of which the benefit of priority is claimed and that is herebyincorporated by reference herein to the extent it is not inconsistentwith the present application.

The disclosed systems and methods also provide a pathway and method forremoving tissue from the cutting area as quickly as it is cut tofacilitate a more efficient continuous cutting process. The removedtissue may be temporarily retained in the housing of the probe but maybe suctioned external to the body immediately after it is cut. In apreferred embodiment, the disclosed systems and methods uses “liveaspiration” through continuous suction or mechanical aspiration toprovide instantaneous tissue removal that transfers tissue externally tothe body as soon as it is severed. “Live aspiration” thatinstantaneously removes tissue allows much longer continuous cuttingsessions since a receptacle in the housing does not fill up and limitthe procedure by the need to be emptied. The faster cutting speeds ofthe coring blades in the present disclosed systems and methodsfacilitate this continuous removal process by cutting tissue morefrequently and cutting in smaller segments to ensure the exit pipelinedoes not become clogged. Since the disclosed systems and methods is notdependent on heat transfer for thermal cutting there is no need forcoring speed (movement of the blades) to be limited by the time it takesfor heat to transfer from the blades to tissue. The sharp edges of theblades and/or burrs alone are enough to severe tissue instantaneously onimpact. Tissue removal is provided by a vacuum suction channel thatintersects with the cutting area of the instrument. Since the suction isvery powerful and applied via linear control during the cutting processthe opening in the housing through which a sharp edge on the cuttingcore interacts with and severs tissue does not have to be closed off orsealed during cutting with dimensions at least as big as the cutout. Theopenings or portals in the housing through which cutting occurs (tissueenters and sharp edges on the core interacting with it) can stay atleast partially open while tissue is severed and tissue will not becomedispersed (e.g., rebounding off the blades) or lost internally becausethe powerful suction pulls it out of the cutting zone and body tooquickly. The mechanism is also supported by “pinch valves” (that may bepresent on the system's console) that close the line to pressure thusholding any liquids or tissues in the probe or suction tubing until itis eventually collected in the single use surgical cassette for biohazardous disposal at the conclusion of the procedure. Continuouslyavailable suction through at least a partial opening in the housing alsoquickly cleans up obstructions like debris, smaller tissue fragments,and fluids in the cutting zone for better visualization and sharpercutting with no blade energy wasted on these obstructions. When thecutout window is completely closed suction is at least temporarilydenied to the region outside the instrument. This temporary lapse ofsuction may permit tissue fragments in this outside region that havealready been severed but not pulled in to scatter. It may also permitfluid(s) to begin to accumulate. Tissue removal is assisted withaspiration and irrigation to keep the cutting pathway and suctionchannel clear by simultaneous infusion of tissue(s) with salineirrigation fluids while draining them. Irrigation may come from thedistal tip at the end of the coring probe body and/or out of the sidesin the distal region or from a separate inlet port or catheterindependent of the coring probe. Preferably, irrigation comes from thecircumference ends and sides of the probe body for faster more efficientflushing and tissue removal. Preferably, irrigation is self-irrigationcoming directly from the probe body itself rather than a separateinstrument or catheter.

The disclosure includes a multi-modal cutting probe that allows the userto: cut with more than one blade, select a different type of blade, cutfrom more than one location on the probe body, move the blade(s) in morethan one range of motion (ROM) or pattern, power the blade with one ofseveral different power sources, adjust the speed of the blade(s)′cutting motion, select between continuous, pulsed and intermittentcutting, and/or supplement mechanical cutting with one or more secondarytherapies (e.g., ultrasonic vibrations) all from the same instrument.

Disclosed systems and methods are designed to function as part of aminimally invasive surgical system and approach that removes the minimumamount of prostate tissue (typically around 33% volume or 20 grams foran average 60 gram sized prostate) necessary to healthily restore thenatural flow of urine from the bladder through the urethra adjacent theprostate while also minimizing and/or eliminating urethral trauma andscar tissue to minimize pain, shorten procedural recovery time, andmaintain normal bladder neck musculature/function, seminal vesicleejaculation, reproductive potency, and delivery of semen.

A method of removing prostate tissue can be summarized in three steps:(1) access, (2) removal, and (3) hemostasis. The atherectomy probe ofthe disclosed systems and methods are part of the removal step. Theaccess and hemostasis aspects are addressed in more detail in commonlyowned application Ser. No. 61/086,775 and Ser. No. 61/120,115. To theextent these applications (61/086,775 and 61/120,115) are notinconsistent with the present application they are hereby incorporatedby reference herein. The cutting probe is designed to be used with andwithout several other individual components including: a protectivedelivery sheath (e.g., balloon and/or lubricated sheath to protect theinsertion lumen such as urethral canal, rectal canal, perineum region,or laparoscopic, umbilical, or other endoscopic passageway), alancet/trocar blade/stylet system that provides access to the prostatefor the probe, fiber optic camera visualization and illuminationcomponents built-in to the probe or as part of a separate probe, polyethylene glycol (PEG) plug or other hemostatic agents, tamponadingballoons, a sealant and/or hemostat that may be again added ifnecessary, a hemostatic agent delivery device, an identificationcassette and/or card for attaching to the console, and a surgicalconsole that contains one or more pinch valves to control linearaspiration, fluid irrigation and residual vacuum that builds up in theflexible tubing lines connected to the probe's vacuum suction system.These additional components may be used with the probe as needed and arenot all needed all of the time.

In the “access” phase, optionally, a pre-lubricated protective deliverysheath that is pre-labeled with depth dimensions (“measurement markers”)is inserted through the urethral canal in a deflated, tubular-rolledcondition. The protective delivery sheath may have a clear ortransparent distal tip and can be inserted over a guidewire or pushedwith an insertion device. Once the protective delivery sheath isinserted to the desired depth within the body (as may be determinedbased on a reading of the measurements on the sheath's outer cover, andanatomical visualization is confirmed via the illuminated fiber opticcamera) the cover peels away and inflation of the protective deliverysheath begins. When used on the sheath, the measurement markers informthe physician and medical personnel how deeply the sheath has beeninserted within the urethral canal. In alternative methods, access maybe made through other entries and the measurement markers would indicatedepth within other parts of the body: the rectal canal for transrectalinsertion, the perineum for transperineal approaches in which dilatingor end-cutting trocar(s) could provide a working channel and clearaccess to the prostate's capsule with a minimally invasive introduction,or could assist with providing depth within the abdomen for laparoscopicentry or umbilical entry, or insertion depth in any other part of thebody for endoscopic or open surgical entry anywhere.

A pre-lubricated delivery sheath is not essential to the presentdisclosed systems and methods but is included in some embodiments of theBPH system/kit. It may also be used in other passageways whennon-urethral approaches are used. The sheath involves an extra stepbefore introducing the coring probe but for very sensitive patients orthose with a damaged or especially narrow passageway the enhancement itprovides in patient comfort and increased hygiene may be worth the extratime it takes. The sheath increases hygiene by providing an extrabarrier between the outer surface of the probe body and the inner wall(or damaged inner wall) of the passageway. If the patient has a healthyaccess passageway (e.g., urethral canal) and/or the outer surface of theprobe itself is sufficiently smooth the sheath can be avoided. The probemay incorporate additional features on its outer surface in order tofacilitate its introduction and better justify avoiding the sheath.These additional features may include a sterilized non-metal spongyouter layer with some resistance and shock-absorbance, the gradualelution of lubricants stored within, a flexible or partially flexibleshaft, etc. If the coring probe's outer surface includes some of theseadditional features the pre-probe delivery of a lubricated sheath mightbe avoided even in sensitive patients with compromised passageways.

Measurement markers that designate depth may be provided directly on theprobe body itself. Like the sheath markers, these markers will let thephysician know how deeply the probe is within the access passageway andare especially important if the sheath and probe become misaligned or ifthe sheath is not used. Additionally, since the probe goes on past thecanal to enter the lobes of the prostate, the markers are especiallyhelpful here for the physician to determine whether the coring probe hasbeen inserted sufficiently deep (e.g., before and during activation ofthe mechanical coring operation) to reach the prostate's core whileavoiding unnecessary penetration. By reducing uncertainty, the markersinhibit overly aggressive coring and thereby assist to preserve amaximum amount of healthy prostate tissue. Typically, around 66% ortwo-thirds (usually around 40 grams) of the prostate can be left intact.

When the protective delivery sheath is used, initially, the sheath maybe inflated only to nominal pressure so that it unrolls from itsdeflated, tubular-rolled insertion condition and expands to occupy theentire natural diameter of the urethral lumen.

With the protective delivery sheath in position at nominal pressure, theilluminated fiber optic visualization system may be connected to theconsole. Fluid delivery and aspiration ports may also be connected tothe console. The surgical console can control infusion via a pump oralternatively, an intravenous (IV) infusion bag (e.g., on a pole) andcan control infusion via gravity with a pinch valve or manual adjustmentto the IV tubing set. A pump may be used for fluids that must bedelivered with forces that cannot be achieved with gravity alone. The IVpole may be actuated via a foot pedal that raises or lowers the IV poleto adjust irrigation or infusion of a coolant fluid (i.e. cooled saline)within the sheath or within a light pipe camera system.

A medical procedure may be initially started in clinic withpre-evaluation sizing and mapping of the target areas that need to becored using ultrasound imaging to create a strategic map. During theprocedure, the transrectal ultrasound system may be deployed tovisualize and confirm the strategic removal of core prostatic tissue.Based upon the measurements confirmation, the “Surgical Procedure Pack”will be opened. The contents may include the disposable products listed:blade, trocar set, cassette with tubing lines, atherectomy probe,transrectal ultrasound probe cover with safety technology, urethralmicro camera with safety technology for live visualization of urethraldecompression and sub tissue probe visualization via LED (Light EmittingDiodes).

The physician may start with insertion of the transperineal ortransurethral camera and transrectal ultrasound for visualization. Thecamera may be provided directly on the probe body itself. Thetransperineal incision will be based upon the surgical grid that willprovide the desired/strategic coordinates to access the target coretissue that was diagnosed during pre-surgical analysis.

Next, with the fiber optic system in position, the anatomic landmarksfor the removal of bulk tissue within the prostate should be againascertained (e.g., parts of the medial and posterior prostate thatappear to be putting the most pressure on the urethra, especially aroundthe bladder neck). Optionally, a fiber optic camera and a source ofillumination (e.g., light emitting diode (LED)) for direct visualizationcan be built into the shaft of the atherectomy probe itself.Alternatively, the fiber optic camera and light source may be part of aseparate probe or included in a light pipe system extending througheither a separate probe or as a channel along the atherectomy probe'sshaft or within the atherectomy probe's lumen. The illuminated camerasystem and the atherectomy probe may also both be elements alongchannels in the body of an endoscope.

After determining the pathway coordinates the physician may create asmall skin incision in the perineum. The physician may then insert thetrocar system with the assistance of transrectal ultrasound guidance andthe surgical grid to non-invasively dilate the perineal tissue and guidethe trocar to the prostate's capsule. Once trocar dilatation has createda sufficient working space, the micro-puncture tools may be used tocreate the access into the prostate's core through a tiny opening in theprostatic capsule that preserves the capsule's basic shape andstructure. The blade may then be removed and replaced with a RadialReciprocating Atherectomy Probe (R2AP or “RRAP”). The probe may beinserted through the surgical grid and activated upon safe anatomicalconfirmation.

A stylet blade may then be inserted into the urethra and activated(similar to an ink pen with a pushable button) to deploy the blade thatis used to create the “micro puncture” in the urethra wall and thenextends to create a second micro puncture of the prostatic capsule ofthe medial lobe's core to create working space for delivery of theatherectomy device. In addition or as an alternative to micropuncture,dilation may be used to create the working space, including withprogressively dilating trocars and other means beyond traditionaldilation balloons.

To assist in properly placing the probe, a grid system may be utilizedsimilar to how a guidance grid can be utilized to insert radioactiveseeds into the prostate to kill tumors with brachytherapy. The gridsystem may comprise a physical template with variably sized holes andoptionally, performed under ultrasound guidance for better accuracy. Thetemplate holes are large enough to accommodate the coring probe shaftand the variable sizes used in conjunction with a tapered shaft on theprobe allow a safer insertion with depth control. When a coring probewith a tapered shaft is inserted in the bigger holes on the template itwill reach more deeply then when it is inserted in the smaller holes.Ultrasound guidance can be used to inform the best holes in the templateto use in order to reach the best coordinates (X,Y,Z) for mechanicalcoring therapy.

The surgical grid provides guidance. The system has alphabetic columnsand numeric rows with restricted corresponding open ports that onlyallow certain predetermined targets and tissue depths based upon theI.D. of the grid and the tapered shaft of the probe. The probe's taperedshaft may also include depth markers that can be visually seen by theoperator. This technology ensures safety with reduced or eliminatedpatient injuries related to introducing the probe beyond the bladderneck and damaging the bladder, or delivering the probe too far inanother direction which could cause a transrectal perforation.

To further guide the probe in reaching the prostate and staying withinthe perineum an alarmed sensor system may be provided that providespositive and/or negative feedback to signal to the operator that theprobe is placed properly or approaching an unintended structure andoff-track. A sensor (e.g., transmitter) on the probe tip may communicatewith one or more sensors (e.g., receivers) on other probes or attachedto other parts of the body to provide positioning feedback. For example,a sensor on an ultrasonic rectal probe cover may receive a signal fromthe transperineal probe tip transmitter and let the probe operator knowif the transperineal probe gets too close to the rectal canal.

The removal phase may begin with the insertion of the atherectomy probe.The atherectomy probe may be inserted alone or optionally, through theprotective delivery sheath, after the probe is connected to the console(including the power supply).

With the RRAP in position the atherectomy probe is activated and coreprostatic tissue may be removed under live continuous observation andcollected into the clear disposable cassette on the surgical console.Meanwhile, the transurethral camera actively searches for decompressionof the predetermined treatment areas within the prostate throughout thecoring operation and tissue removal process. This core de-bulkingincludes targets such as the bladder neck, median lobe, and other areasthat are determined during a pre-surgical analysis and recorded on apre-surgical worksheet.

After the target areas show visual decompression, and the cassettesystem shows a visual estimation of target tissue removed, the procedurecan be completed or the areas may be re-treated again via the sameprostatic micro puncture. Ultrasonic pictures are suggested forprocedural documentation to measure pre- and post-surgical resultsdemonstrating a volumetric reduction. Pictures may be taken immediatelyafter surgery and during a patient's follow-up in the days to come tomonitor healing progress.

Once the procedure is completed the atherectomy probe may be removed andthe micro puncture to the prostate's capsule evaluated. A few minutes ofdirect pressure may be applied to assist with hemostasis. A hemostaticagent may be applied to achieve hemostasis if indicated. Many productsmay be used at this time, such as fibrins, glues, thrombins, and as alast resort cautery.

With the target location(s) in view the atherectomy probe may beinserted into the core of the lobe and then activated to perform a coreprostatectomy removing target bulk tissue regions of the medial andposterior prostate. The coring procedure may remove approximately 30% ofbulk tissue from the medial prostate and at the surgeon's option it mayalso remove approximately 20% of bulk tissue from the posteriorprostate.

Following the initial de-bulking of the core prostate in the anterior,medial, and/or posterior lobes, the urethral canal may be inspected foradequate urethral diameters to ensure the normal flow of fluids(bladder, semen, etc.) post-procedure. If there is still limited flow orthe flow of materials is inadequate, additional core prostatectomytherapy may be performed to remove the excess bulk tissue andconstrictive pressures until flow is restored.

The blade used to create the micropuncture and method of its useprovides self-sealing wound architecture embodied in a tiny gateway toremove problematic hypertrophied core prostate tissue while minimizingthe impact of the procedure on the majority of the healthy prostatetissue. As a complement or substitute to micropuncture, progressivedilation may be used to gently and gradually expand a working spacewithin the prostate without as much cutting/dissecting as traditionalsurgery. Dilating rather than cutting may preserve the healthy prostate.The smaller cuts made with micropuncture access also preserve prostatecompared to more traditional cutting and broader application of energytherapies. Progressive dilation may be accomplished by sequentiallyinserting a series of larger and larger co-axial dilators over a centralsharp trocar or guidewire. The cutting edges of the mechanical coringprobe also may provide self-sealing wound architecture that minimizesthe amount of post-procedural scar tissue formation so that thevolumetric reduction from removal is not undone by aggressive scartissue growth. Optimally, the wound architectures created by themicropuncture, dilation, and mechanical coring instruments areself-sealing in that they preserve the prostate to such an extent andhave such a limited region of impact that hemostatic devices andtamponading balloons can in many cases be avoided completely as thesmall openings will naturally close. Natural closure or closure withminimal hemostatic devices may provide an advantage over devices andmethods that seal with heat. Using self-sealing natural closure ornon-heating hemostatic devices and methods damage may be avoided.

If the flow through the urethral canal is adjudged to be adequate, thenthe hemostasis phase of the procedure may begin.

When necessary additional hemostatic agents may be used such as theinsertion of a poly ethylene glycol (PEG) plug into the cored lobe. ThePEG plug may be deployed by retraction of a sheath on a delivery device.Once the plug is properly placed, inflatable tamponading balloons may beused over it to direct pressure evenly and to create closing pressureonto the PEG plug. This multi-component system in the medial lobe's coreachieves hemostasis from both direct pressure tamponade and activationof the PEG plug. The balloons may be inflated with an incompressiblecoolant fluid (e.g., cooled saline solution) for reduced inflammationand pain, reduced bleeding, improved stability, and greater patientcomfort and satisfaction. The coolant fluid balloon tamponadeprostaplasty system should remain in position for approximately threeminutes to provide an adequate tamponade effect. After the first threeminutes the site may be inspected for stability upon minimal deflation.If bleeding is still present, the balloons may be re-inflated to fullinflation and the tamponade may remain in position for approximatelyanother three minutes. This seal, hold, and inspect cycle may continueuntil the atherectomy site demonstrates stability showing no furtherbleeding. Minimal drainage may be permissible. As necessary, othersealant products (e.g., gels, powders, patches, plugs, etc.) may beadministered (i.e. adhered, applied, injected, inserted, plugged,sprayed) after removal of the balloon tamponade system, including:thrombins, fibrins, fibrin glues, gelatins, platelets, etc. derived fromhuman, bovine, porcine, synthetic, etc. sources.

A supplementary, complimentary, and/or alternative means to achievehemostasis is to use a microscopic end cauterizing probe to supplyenergy to seal the site. The probe may be bipolar or monopolar and itcan emit any one of several forms of energy to accomplish such sealing:electrical, laser, microwave, radiofrequency, resistive heating,ultrasonic, etc. The probe may be inserted into the body through theprotective delivery sheath or without the sheath if the probe's outersurface and structure are sufficiently atraumatic. The probe may bedirected through the micro puncture site in the urethral wall andprostatic capsule to reach the core prostate. At the core prostate, thecauterization probe may be activated briefly to achieve hemostasis andseal the zone from which bulk tissue was removed.

The disclosed atherectomy probe may have one or more cutting edgesprovided in a distal region of a cutting core within a housing. Both thecutting edge and the cutting core should fit within a circularinstrument lumen. The cutting edge may be in the form of a blade or anyother design. The cutting edge may have any one of several shapes solong as at least some edges of the shape are sharp enough tomechanically cut, miniaturize, and release tissue with minimal effortand minimal exertion of contact pressure. For example, the blade(s) maybe linear, V-shaped, X-shaped (criss-cross), U-shaped arch, triangular,rectangular, hourglass, circular with sections (like pie slices)missing, rotating bur (also burr; as used herein “bur” or “burr” ofeither spelling also refers to and includes the term with the otherspelling), etc. The edges of the blades are preferably orientedperpendicularly or at an angle (i.e. diagonally) to a longitudinal axisof the probe body. However, in end cutting embodiments the edges may beparallel to the longitudinal axis of the probe body, pointing outwardfrom the distal tip. For embodiments in which two or more cutting edgesof the blades come together to cut, the edges should be parallel to oneanother (or at least parallel in segments but need not be straight) andpatterned to match-up (corresponding) like pieces of a puzzle. However,only one cutting edge is necessary and this one edge may operate bysupplying pressure to tissue against the probe housing acting as abuttress instead of coming together with another edge. A singularcutting edge could also come together with another non-sharp moveableelement that serves as a moveable buttress rather than a cutting edge.Alternatively, a buttress for a cutting edge is not necessary as thecutting edges may be sharp enough to sever tissue instantaneously onimpact by shear mechanical force (high speed). Pointed barbs,burs/burrs, triangular blades, wires or blades etc. may simply protrudefrom the instrument body to interact with tissue unilaterally without anopposing buttress.

There may be a stationary (non-moving) partial hood that partiallycovers the moving blades and shields the cutting zone. The hood mayprovide added stability and safety by reducing or eliminating theprobe's desire to move back and forth. Additionally, the hood may allowthe probe to be placed within close proximity to anatomy that is notintended to be damaged or removed (non-target anatomy) without trauma.The hood may provide protection from the cutting mechanism for thosesituations.

As another safety feature, the linear control of aspiration may be usedto minimize the aggressiveness of suction and tissue attraction to theblade. In conjunction with the hooded tip, linear aspiration providesexcellent surgeon control. The hood may or may not have sharp edges toassist with cutting as well.

The blade(s) mounted on the cutting core may protrude from one or moreopenings or portals in the housing to interact with tissue. Any numberof openings with any shape may be provided. For example, see FIG. 8-FIG.10 and FIG. 12 showing an embodiment with four gum-drop shaped openings122 in the housing with its protective dome-shaped cover or hood 121.The opening(s) 122 within the housing may be positioned at the distaltip and/or along one or more lateral sides in a distal region (thelatter arrangement is shown in FIG. 8-FIG. 10 and FIG. 12). The insideedges of the openings or windows may be sharp such that as tissue issqueezed through an opening and pressed against the inside edge(s) bythe blade it is cut from more than one direction by both the window'sinside edge and by the blade.

There may be at least two openings in the housing to provide dual portor multi-port cutting. There may be four openings for a quad portdesign. Increasing the number of openings or cutting ports has theadvantage of providing multiple edge points for more opportunities toshear cut tissue. As a result there are a greater number of smallershear tissue cuts. Many small tissue cuts reduces the likelihood ofclogged aspiration lines and also reduces the likelihood of the probebecoming stalled in thick, dense tissue, as compared to fewer largetissue cuts.

There may be at least one opening in the housing at a distal tip and atleast one opening along a lateral side to provide the option of eitheror both of end-cutting and side-cutting action. In dual port andmulti-port embodiments in which the cutting core can interact withtissue to sever it at more than one location the cutting action indifferent portals may be performed alternatively, sequentially(including alternating or cyclical), or simultaneously. Additionally,when there is more than one portal or opening in the housing the cuttingstyle or mechanism at each portal/opening may be the same or may bedifferent. FIG. 8-FIG. 10 and FIG. 12 show a quad port embodiment withfour lateral portals and radial reciprocating side-cutting at allportals. There may be two lateral portals with guillotine side-cuttingin one portal and radial reciprocating side-cutting in the other portal.Another embodiment may have the aforementioned two portals (guillotinelateral and radial reciprocating lateral) with an additional distalcutting portal doing circular end-cutting (i.e. such as with a pointedburr).

The characteristics of the openings and the blades may be adjusted asneeded to achieve a preferred cutting style. For example, the openingsmay be larger or smaller with thinner or thicker struts. The sharpnessof the blade and the angle at which the blade passes through the openingto contact and severe tissue may also be adjusted. The inner cuttingedge of the blade may be sharp enough to easily sever tissue uponcontact.

When there is more than one lateral portal the portals may be lined upaxially along a longitudinal axis of the probe body. When the portalsare lined up axially their radial locations about the periphery of theprobe are identical. Alternatively, more than one portal may be lined upradially around the periphery of the probe body. When the portals arelined up radially their longitudinal positions from a distal or proximalend of the probe body are identical. Multiple cutting portals may alsobe offset (not lined up) axially and radially such that they arerandomly staggered or form a pattern such as diagonal, zig-zag, helical,etc.

The cutting core may have at least one sharp edge for severing tissue.Multiple sharp edges may be provided. The sharp edges may be provided inthe form of blades with a linear edge or in any other mannersufficiently sharp enough to sever tissue. The sharp edge may be in theform of one or more piercing distal tip(s) on one or more pointedbarb(s) or burr(s). When the sharp edge is provided by a blade the edgemay be flat, smooth, and straight or it may be jagged and textured.

The sharp cutting edges (e.g., blades, barbs, burrs) may be extendablethrough a push-button actuation mechanism similar to a push-button ballpoint pen. With this mechanism the push of a button functions to extendthe cutting edge(s) and/or to retract the housing covering the cuttingedge(s). Multiple pushes of the button may incrementally adjust thedegree of extension of the cutting edge(s) (i.e. the length of theblade). When there are multiple cutting edges at differentopenings/portals in the distal region of the probe housing they may beindependently extendable/retractable with multiple push-buttons and abutton corresponding to each cutting edge or group of cutting edges.

The direction, pattern, and range of motion for the blade may also vary.One such cutting pattern is guillotine in which the sharp cutting edgeof a blade descends to sever tissue stabilized between the actuatingblade and a wall or other part of the shaft which creates a shearingeffect for a smooth cut edge. The guillotine cutting pattern operatessimilar to a paper cutter in embodiments in which the buttress base(e.g., wall of shaft or another part of shaft) is straight and parallelto the blade. This planar slicing mechanism (guillotine) can beside-cutting when it occurs on a lateral side of the device or a modestform of end-cutting (positioned at a distal end but not protruding).

Another cutting mechanism is radial reciprocating in which the blademoves in an arc. The blade rotates in an arc from left(counterclockwise) to right (clockwise) motion (or vice versa) and cancut on one side or the other or both as desired. Generally, but notexclusively, the sharp edge of the blade comes down vertically (distalto proximal or vice versa along a longitudinal axis of the instrumentbody) for guillotine and horizontally (around a longitudinal axis of theinstrument body) for radial reciprocating.

In a radial reciprocating pattern the blade moves radially throughout avariable bounded range (e.g., 30 degrees, 45°, 60°, 90°, 120°, 135°,150°, 180°, 210°, 225°, 240°, 270°, 300°, 315°, 330°, 360° etc.). Themaximum range of rotation may be a complete circle of 360 degrees. Oncethe blade reaches the bound of the motion range instead of continuing onin the same direction (right/clockwise or left/counter-clockwise) it maychange direction and re-traverse the same path in a different direction.

A third mechanism for cutting is a circular motion pattern similar tothe movement of a drill head. In a circular cutting pattern the bladerotates radially but continually moves further and further in the samedirection (e.g., right/clockwise or left/counter-clockwise). Thecircular atherectomy cutter spins inside of the shaft and cuts tissue byhaving the sharp blade or bur/burr portion engage the tissue against theshaft or with direct pressure to sever and miniaturize for aspirationand removal.

A fourth mechanism for cutting is end cutting. End cutting involves oneor more blades situated at or protruding from a distal most tip of theinstrument. Typically, the blades extend straight or at an angle betweenan orientation parallel to the instrument body and an orientationperpendicular to the instrument body (i.e. oblique or transverse). Theblades may resemble those at the base of a blender machine in thekitchen. The range of motion or cutting pattern of the protruding bladesin an end cutting device may be reciprocal, radially reciprocal, orcircular/rotating. In an alternative end cutting embodiment similar totypical side cutting the blade(s) may simply be situated at a distal endof the instrument rather than protruding from it. The blades maytraverse a distal cross-section of the probe lumen to perform withreciprocating or guillotine cutting styles.

The power or pressure source that motion can also vary betweenembodiments or between modes in a single embodiment. To some extent thepower or pressure source to be used depends on the motion patterndesired for the blade. Some motion patterns work better when actuated bycertain sources of power or energy than other sources. Blade actuationmay be continuous, pulsed, and/or periodically pulsed. Regardless ofwhich power source or actuation means is used to drive the cuttingblade, all actuation takes place at the proximal end of the instrumentoutside the body of the patient. The actuation process occurs in thehandpiece and the cutting action/motion is delivered down the shafttoward the targeted bulk tissue in which it is engaged by its operator.There may be a power generator in the handpiece to initiate theactuation process. The power generator may produce pneumatic orelectrical energy to drive the cutting core.

The power generator may be an ultrasonic generator that operates at highfrequencies in the range of 50,000 Hz. This ultrasonic generatorobliterates tissue into tiny morsels of emulsified “mush” that can beeasily removed via aspiration. The delivery of ultrasonic energy to thecore prostate can be used as a substitute, a compliment, or a supplementto other forms of core prostate removal (i.e. mechanical cutting). Theuse of mechanical cutting before or during ultrasonic energy applicationshould accelerate the emulsification process by creating smallerparticles for the ultrasonic energy to act upon, thereby concentratingits effects. Ultrasonic energy would be used in much the same way asphacoemulsification is in cataract surgery to obliterate a thickenedlens. “Live aspiration” would evacuate the obliteratedmorsels/emulsified “mush” through one or more openings in the distal tipof the probe via a continuous process of irrigating (via end and/or sideports) and aspirating (or suction). The ultrasonic generator mayincorporate microprocessor-controlled fluid dynamics based on aperistaltic or venturi type of pump.

The power source that drives the probe may be pneumatic. In pneumaticactuation, the exhaustion or decompression of a gas (e.g., air) or acompressed gas (e.g., nitrogen) is used to drive pistons that transfertheir energy into blade motion and actuation. Pneumatic actuation isappropriate for guillotine, radial reciprocating, circular/rotating,and/or end cutting action. Pneumatic power may be used to drive radialreciprocating blade action.

Another power source is hydraulic. In hydraulic actuation, the motion ofa liquid (e.g., water) is used to drive the motion of the blade.

A third power source is electric. Electrical energy can come from aconventional power outlet. The instrument preferably can run off ofalternating (AC) or direct (DC) current. The electric system can also bebattery powered. Electric energy is ideal for powering a blade in acircular cutting pattern.

A fourth power source is solar energy. The cutting probe may optionallybe designed to charge upon exposure to solar radiation. Solar energy isan indirect power source for the cutting element in that it is firstconverted to electrical energy.

A fifth power source is manual mechanical energy as controlled by anoperator. This manual source can be used for any of the cutting patternsbut may be easier to administer with some than others. For example, itmay be easier for a user to turn a nob back and forth for radialreciprocating motion than to continually readjust one's grip and keepturning a nob in the same direction as for circular cutting.Nonetheless, in a well-designed device manual mechanical operation bythe user could be used to easily and smoothly actuate any cuttingpattern.

In any of the aforementioned embodiments (any type of blade, any rangeof motion, any power source) the instrument is designed with variouschannels. Some of these channels are necessary and used for basicfunctions such as removal of severed tissue while others are optionaland used for auxiliary or supplemental therapies.

The basic function channels are for: tissue cutting, tissue removal,live active suction or withdrawal of fluids, self-irrigation or flushingwith fluids, and drainage of fluids. Tissue removal may be accomplishedwith a pathway large enough to transfer an evacuation force strongenough (e.g., vacuum suction, peristaltic pump, piston system, venturivacuum) to keep pace with the rate at which tissue is severed, and withthe volume at which severed tissue is generated to avoid accumulation ofnecrosed tissue. Prompt removal of necrosed tissue keeps the cuttingmechanism strong, efficient, and maintains optimal direct visualizationas well as keeps the exit pathway clear and effective, thus reducinginfection, internal redistribution and the potential risk ofcomplications associated therewith. Irrigation provides consistentsmooth aspiration and reduces air locks to keep the aspiration andtissue removal process running interrupted.

Channels may also be provided within the probe body to deliverpharmaceutical drugs and other therapeutic medicinal agents directly atthe target site. Examples of drugs that might be delivered includeantibiotics to prevent infection, and antiproliferatives to control scartissue formation.

Other channels in the instrument may be used to provide a secondary oralternative therapy that augments the primary mechanical cuttingtherapy. The secondary therapy may be one that is powerful enough to beused independently to reduce the size of the prostate and to relieve thesymptoms of BPH. Performing a little mechanical cutting action to exposethe more sensitive and vulnerable inside of tissue and then applying thesecondary therapy may be more effective than applying the secondarytherapy alone. Mechanical cutting can be used to identify and literallycarve out a target site so that any other therapies can be used in areduced amount and applied with precision focus, reducing their impacton nearby healthy tissue. Heat therapy may provide tissue cauterization,coagulation and hemostasis before, during, or after cutting. Heattherapy may be provided by heating the sharp mechanical cutting blades(e.g., one or more heated end cutting burs such as by adjustingdiathermy controls on a central console.

Hemostasis may be provided by a hemostatic agent, such as a PEG plug,deployed from a retracting sheath on a delivery device. The deliverydevice may have an ergonomic handle with slots for a medical operator'sfingers and thumb to avoid instrumentation slippage. The hemostaticagent delivery device may have a safety clip to prevent premature and/oraccidental deployment. The inflation of tamponading balloons (via aprostaplasty system) should follow placement of the plug for extrasealing reinforcement and more evenly distributed pressure upon the plugand throughout the cavity.

In some cases, using the minimally invasive techniques described herein,hemostatic devices such as tamponading balloons and sealants should notbe necessary. Using either the micropuncture or progressive dilationapproaches to access the prostate maintains the natural prostaticcapsule so that it can incarcerate the surgery zone and naturallycontrol bleeding. If the incision is small enough and dilation gentleenough (and depending upon the patient) hemostasis will occur naturallyupon removal of the instruments due to preservation of the capsularshape of the prostate. As the prostate returns to its natural shape uponremoval of dilators bleeding should subside. A surgeon's digitalapplication of direct pressure through the rectum can be used toinitiate natural hemostasis in the prostate while waiting to see ifauxiliary hemostatic devices are going to be necessary.

When auxiliary hemostatic devices (e.g., balloons, sealants, plugs) areused, it will be found that the small opening created with themicropuncture and/or the small cavity formed through progressivedilation to provide access to the prostate and shape a working space isjust the right size to accept a hemostatic plug. Sometimes this smallopening and working space will close-up on its own as instruments areremoved and the preserved prostatic capsule quickly rebounds. However,in some patients with less elasticity in their tissue, blood thatdoesn't clot easily, and/or in those with diseased prostates in whichadditional prostate tissue must be removed the rebounding process isslow and/or incomplete requiring the use of hemostatic devices tocontrol bleeding at least in the short-term until natural healing canoccur.

The body of the atherectomy probe may be flexible to navigate thenatural bodily lumens that are typically somewhat tortuous. Thisflexibility may be provided by the material from which the body is madeincluding soft metals with shape memory (such as nitinol, cobalt, andchromium), plastics, or elastomeric polymers. The flexibility may alsobe provided by a segmented body capable of angular and/or radialrotation at the segment junctions. The individual body segments may bestraight or curved to create sharp turns or smooth waves when they arebent. The blade itself may optionally be made flexible unless lockedrigid. This would reduce damage done from inadvertent instrumentmovement when the blade is exposed but not locked. Flexibility in theblade would allow it to spring back upon compression into tissue ratherthan piercing right into tissue.

The blade itself may be made adjustable independently from theinstrument body. For example, the position of the blade within the bodymay be controlled to move the blade from a position protected within theshell of the housing to the distal end of the body for sheltered cuttingand optionally, to extend past the distal end of the body for exposedcutting. Thus, the blade may be longitudinally and/or radiallyextendable. Preferably, this is accomplished through a push-buttonactuation mechanism with a locking option (in either retracted orextended position) and a quick release safety feature to immediatelycollapse the blade from a locked extended position.

Anatomical dimensions vary from person to person including the diametersof the urethral canal, bladder neck, and seminal vesicle. Accordingly,it would be useful to be able to adjust the diameter of the instrumentand the angle and/or length of the blades in situ. The objective is toensure that there is adequate pressure between the blade of theinstrument and the tissue when the instrument is in position to cut atarget site without any pressure when the instrument is being insertedto or withdrawn from the target site. One way to achieve these variablediameters of the atherectomy instrument and its blades is for the distalend of the probe to include a flanged segment that tapers outward to cutand can be retracted back inward for passage. The flanged segment mayretract radially (by turning) and/or longitudinally (i.e. in atelescopic manner).

Although the mechanical manipulation of the cutting blade and instrumentbody will be sufficient in most cases to provide the necessary tractionagainst tissue for cutting, additional devices and methods may beutilized to enhance the contact pressure between the sharp end of theblade and the tissue which is to be cut. One device for creatingadditional pressure between the cutting blade and tissue is anexpandable balloon. The balloon can be part of a separate balloondilation instrument or it may be part of the atherectomy probe itself.Tithe balloon may be deployed along a side of the atherectomy probe on aside opposite the action of the cutting blade such that its inflationpushes the cutting blade into tissue. With the balloon outside the bodyof the probe it does not interfere with the tissue removal and otherchannels (e.g., irrigation, drainage).

The probe may include a means for detecting and characterizing tissue.This element would be capable of distinguishing target tissue (e.g.,unhealthy hyperplastic regions) and then characterizing the targettissue (e.g., density, thickness/depth). The detection andcharacterization means should be employed prior to beginning cutting inorder to direct the modalities (e.g., blade size, sharpness, cuttingpattern, rotations per minute, suction level) chosen for the cuttingoperation. One such means could be an ultrasonic sensor that emits soundvibrations to determine tissue depth.

BPH or prostate cancer may be treated as disclosed herein withoutburning lasers, without rectal probes, and without mass ultrasonicusage. Since electrical or pneumatic energy is used to mechanicallydrive the sharp cutting core of the atherectomy probe, the system can bemade compactly as compared to systems that require large complex systemsto generate microwaves, radio waves, ultrasound, vapors, heated water,etc.

The removal of only modest amounts of the medial and posterior prostatecan adequately reduce impingement within the urinary and seminalchannels. The post-procedure improvement results in the expansion of thechannels substantially back to their pre-BPH diameters with a preserved,healthy, and smooth urethral lining for a natural release of urine andseminal fluids.

The procedure begins with the insertion into the urethra of aretrievable protective delivery sheath (e.g., inflatable balloon and/orhighly lubricated sheath). The inflated protective delivery sheathserves as a channel to create space for and protect the urethral wallfrom both the visualization probe and the atherectomy probe.

The atherectomy probe also fits within the protective channel formed bythe inflated protective delivery sheath. The focused, micro invasivedesign requires that only the smallest instruments feasible be utilized.The outer diameter of the cutting atherectomy tool is 1 mm to 4 mm. Theouter diameter of the cutting atherectomy tool may be 2.778 mm. Theatherectomy tool comprises an outer shaft, a multi-piece inner cuttingcore, and an aspiration and live suction tissue removal mechanism. Theouter shaft and the inner cutting core may be composed of stainlesssteel or another suitable material that adds support and providesrigidity to the system to facilitate adequate waste flow for the removalof tissue and fluids. Stainless steel is a sufficient material for thecutting core and probe body, is less expensive than other materials, andmay provide performance advantages over expensive memory metals such asnitinol. The shaft of the atherectomy tool should be approximately 12″(12 inches) from handle to tip for the TUCP™ system and approximately 6″(6 inches) from handle to tip for the TPCP™ system. The handle may havean ergonomic design. The outer plastic handle houses the stainless steelcutting system.

The multi-piece inner cutting core should occupy approximately eightypercent of the total inner area spanned by a circumference of theatherectomy probe. The cutter should be slightly or partially recessedinside of the tip of the shaft so that it only engages tissue that hasbeen directly inserted into the outer port. The design of the cuttingcore may resemble a pie with slices (i.e. two mirror-image slices)missing. The area occupied by the missing pie slices is preferablyapproximately 20% of the total inner area of the circle formed by across-section through the probe. Ultra-sharp cutting blades arepositioned on the edges adjacent the missing pie slices.

As shown in FIG. 11 the cutter may comprises a blade 123 and cylindricaltubular shaft 124 that turns into the aspiration pipe 108 towards itsproximal end. The aspiration line 108 is shown in FIGS. 6-7 geared tothe piston 110. Movement of the piston 110 actuates the gear 115/116 andturns the cutting core 124. Tissue severed by the cutting core 124 iseasily suctioned out of the body since the aspiration pipe 108 and theblade 123 and cutting core 124 are integrated.

The blades may be made of stainless steel. An internal driver isattached to the multi-piece inner core that spins it very rapidly at15,000 rpm to 25,000 rpm. The internal driver may spin the two-pieceinner core at approximately 20,000 rpm. Because heat transfer orcauterization is not required blade speed is not limited. Higher speedsproduce smaller (and more frequently cut) tissue fragments to avoidblockage or kinking in the removal line as from large fragments producedby less frequently cutting slower blade motion. The torque to move thecutter (e.g., via rotation, reciprocation, or slicing movement) can bedriven either pneumatically (e.g., via compressed nitrogen or air) or byan electric motor powered by the surgical console. The handpiece powercord for the cutting core driver is unique from other power cords suchthat its presence is sensed by an identification sensor on the console.

An average prostate size for those with BPH seeking surgicalintervention is around 60 grams. It is expected that de-bulking a coreof 20 grams (around one-third of the prostate) should provide sufficientpatient satisfaction. Thus, the mechanical coring operation should becontinued until a mass of approximately 20 grams has been removed.However, as every individual case is different the physician's bestjudgment should be used to instruct when to stop cutting and in somecases more or less than this amount will be removed to provide adequaterelief.

Four or more pipes, collectively 105 as shown in FIG. 1, extend throughthe proximal end of the instrument and extend distally to differentlengths as necessary. The pipes may be arranged side by side when viewedfrom a cross-section through the instrument as shown in FIG. 2. Thepipes may be arranged left to right as follows as shown in FIGS. 3-4:infusion pipe 109, aspiration pipe 108, power supply pipe 107 (e.g., apneumatic air source according to a preferred embodiment), and means forvisualizing 106 (e.g., a fiber optic cable).

The aspiration pipe 108, as shown in FIGS. 2-7, 13, and 15, is one offour or more pipes (collectively 105 as in FIG. 1). If the cutting coreis shaped like a solid cylinder with pie slices missing, the aspirationvolume is approximately 20% of the cross sectional area of theatherectomy probe left vacant by the inner cutting core. The function ofthe aspiration system is to facilitate the removal of excised tissuefrom the internal surgical site to an external self-sealed biohazardwaste cassette and bag attached to the surgical console via vacuumsuction and irrigation. Aspiration is activated when a luer lockconnector attaches to a unique cassette on an identification-sensingsurgical console. The aspiration line tubing should be transparent andalso include measurements (e.g., cubic centimeters (cm3 or cc's)) sothat the flow of materials, including fluids and tissue, can be easilymonitored and analyzed. Transparent tubing also permits general flowcharacteristics to be observed so that kinks, bubbles, jams, etc. can bepromptly noted and remedied.

Following the removal of sufficient amounts of core prostatic tissue,the site should be sealed to ensure and maintain hemostasis. Any sealingsystem and method known in the art is appropriate including: tamponadingballoons, cauterizing probes, and topical adhesives (e.g., gels,powders, patches, plugs, etc. that can be sprayed, inserted, plugged,injected, adhered, etc. including thrombins, fibrins, fibrin glues,gelatins, platelets, etc. derived from human, bovine, porcine,synthetic, etc. sources). One sealing system and method is the coolingdual tamponade prostaplasty system described herein and also in commonlyowned, U.S. Provisional Patent Application No. 61/048,427 (entitled“Benign prostatic hyperplasia surgical intervention system”, filed Apr.28, 2008) of which the benefit is claimed and which is hereinincorporated by reference to the extent it is not inconsistent with thisapplication.

The controlled access methods (e.g., micropuncture, progressivedilation) and selective removal of core hyperplastic prostate tissueusing the mechanical coring techniques described herein provide theability to relieve stricture at the bladder neck without impairingfunctioning of the surrounding musculature. The urethral lining bladdersand internal and external sphincter muscles are left intact while thecore prostate is accessed and de-bulked including by the elimination ofexcess tissue at the bladder neck and while preserving the prostaticcapsule. Normal functioning of the urethral musculature is importantbecause the regular contract and release cycles are responsible for ahealthy ejaculatory response and for bladder continence and control. Theinternal sphincter is responsible for involuntary muscles that controlthe ejaculatory response. The external sphincter is responsible forvoluntary muscles that control the bladder and the ability to urinate.Damage to the musculature could cause problems such as dry climax,reverse ejaculation, incontinence, and bladder control issues. Thepresent disclosed systems and methods quickly sculpt the prostate torelieve constriction without damaging musculature or the basic capsularshape. The load on the musculature is restored to normal sustainablelevels that save the muscles from the overuse that occurs during BPH tocompensate for the increased pressures caused by hyperplastic tissueimposing upon natural lumens.

Destruction of the natural urethral lining and/or musculature from othermore aggressive, non-selective (e.g., capsule cutting/destroying,urethral lining irritating, and collateral damage to healthy tissue) BPHand prostate cancer treatment procedures can take weeks or even monthsto heal. This healing process is especially slow and problematic inindividuals with diabetes, peripheral vascular disease, and others withcompromised circulatory and/or immune response. The non-destructivetransperineal core prostatectomy (TPCP™) and the transurethral coreprostectomy (TUCP™) devices and procedures described herein would beespecially helpful to these individuals that may otherwise be poorcandidates for other contemporary surgical methods.

Another feature of the disclosed systems and methods is the uniqueidentification sensitive surgical cassette or card that is inserted intothe console to determine the product being used. This cassette connectsto the surgical console and may associate the console controls with thedisposable surgical instruments. The use of an identification systemsupports and maintains FDA mandates on product tracking and ensures thata product is not re-used. Reusing a product could reduce performance andresult in patient injury or infection due to biohazardous, bloodbornepathogens and material contaminants. Such pathogens and contaminantswould be extremely difficult, if not impossible, to clean and sterilizedue to the nature of the small diameter plastic closed/sealed cassettesystem. However, with disposable products it is also important toprotect healthcare providers and others who come in contact withdisposed biohazardous materials. Thus, a sealed biohazardous containmentsystem has been designed for disposal. The ID-sensing mechanism providesa secure way to ensure hygienic instruments while removing the cleaningobstacle and risk of inadequate sterilization.

The cassette may comprise a unique pattern of insulating regions withina conducting material placed in between two other conductive materials.The insulating regions may be composed of air gaps (e.g., a hole-punchpattern) or discrete sections of insulating materials having adielectric constant (permittivity) higher than that of the surroundingconducting material. Within the console, an electric sensor on one sideof the cassette recognizes the cassette that is the “key” according tothe conductivity pattern it creates as measured by, for example, areduced current in certain regions.

The cassette may have one or more exposed tubing sets that allow forpinch valves to actuate against the tubing lines to eliminateresidual/built up aspiration in the lines of the atherectomy probe andwork with the linear aspiration controlled by the operator. The pinchvalves reduce/minimize/eliminate aspiration to reach 0 (zero) mmHg(millimeters of Mercury) aspiration when the operator so chooses toprovide a significant performance/safety advantage. Pinch valves providea way to take control of built up aspiration that may accidentallyincarcerate itself into the cutters port. With pinch valves the tissuecan be released from the cutters port without destroying it.

An encoded surgical identification card similar to a credit or gift cardmay be used. The card tells the console system what product is beingused with lot numbers, etc. Such a card is encoded for only one use andafter being used once becomes permanently deactivated. To use theconsole again a new card is required. A new card is provided with eachnew disposable product purchase (e.g., in the sterile surgical pack thathas the disposable atherectomy probe in it). The surgical consolerequires a new disposable card with each use and the codes embeddedwithin the card are encrypted data that cannot be hacked.

The surgical console serves as an operations control center for theentire surgical system. This console is smaller than those ofconventional BPH treatment systems because no large energy generatingunit is required. The console can simply plug into conventional wallelectrical outlets and use this electrical energy as a source for theatherectomy probe driver and other controls. Back-up batteries can beprovided for use with the system in the event of an external electricalpower outage or brown-out during surgery.

The atherectomy probe cutting core rotation speed can be controlled byeither an electric drive handpiece on an ergonomic handle or a foottreadle. Both the handle control and the foot treadle control connect tothe console. The console display visibly shows the atherectomy speed inRPM (revolutions per minute), CPM (Cuts Per Minute) and as a percentageof maximum capacity. The console also features a third overriding meansto control the atherectomy driver speed along with an emergency stopswitch. All rotation speed controls for the atherectomy probe cuttingcore enable the operator to obtain a range of fixed speeds and to adjustthe speed. The driver shaft includes plastic components and should notbe flashed or sterilized for reuse as it would be impossible to verifysterility and cleanliness of micro internal components for multi patientuse. The atherectomy probe is connected to the console by a first quickconnect relay which connects the driver and a second quick connect relaywhich connects the aspiration line to the sealed single use, disposable,biohazard collection cassette.

Illumination within the light pipe is also controlled through theconsole. The console houses a metal halide, light emitting diode, orxenon light source of at least two bulbs so that a back-up is readilyavailable in the event one bulb burns out. The console light sourcecompartment provides ventilation for the bulbs to dissipate and preventheat build-up. The light source compartment of the console can be easilyaccessed at the conclusion of the procedure and allows easy maintenanceand exchange of bulbs without interfering with the other displays andinstrumentation controls on the console.

Preferably, a light is built into the probe body. This light can bepowered by and have its source in the console or independently withinthe probe handpiece or shaft. The probe light should be capable ofvisualizing the probe tip to operate in coordination with a urethralcamera. Together the urethral camera and probe light focused on the tipcan track the location of the probe in sub tissue below the camera andevaluate the progress of the procedure, including its relief to thetarget stricture, in “real time”. This feedback enhances efficiency byallowing instrument positions to be adjusted promptly as needed andenabling the full amount of coring to be achieved before instruments arewithdrawn so that they don't have to be reinserted to finish the job.

The console also has a docking station for the surgical cassette.Through an identification sensing mechanism, the console detects thecassette/card to activate the peristaltic pump which engages theaspiration tubing lines of the cassette. The cassette has two aspirationlines attached to the pump to provide a back-up in the event one linebecomes clogged or kinked. All aspiration and pump lines are fitted withluer locks for quick and easy assembly and detachment.

Any commercially available medical facility endoscopic camera andmonitor system can be attached to the console via a quick connect portand the use of adaptors.

The console screen displays all control variables in well-lit, large,easy-to-understand symbols. Up and down arrow control buttons areprovided for adjusting: the illumination, the atherectomy probe cuttingcore driver rotation speed, and the aspiration rate via the vacuumsuction from the console's internal peristaltic pump. A second internalperistaltic pump could also be used to control coolant infusion speedsbased upon foot pedal position or console adjustment controls.

A review of the illustrations and identification of the referencenumerals follows.

FIG. 1 shows the entire mechanical coring atherectomy probe looking fromthe proximal (at lower right) towards the distal end (at upper left). Atthe distal end is the cutting shaft covered with a thin,tightly-wrapped, opaque cover 101. Underneath the cover 101 is the lightsheath 125 which surrounds the cutting core 124, the cutting core 124becoming a blade 123 distally and an aspiration pipe 108 proximally.Proximal to the opaque cover 101 is a first and distal tapered portionof the handpiece 102 that encompasses the light cone 113, followed by asecond intermediate curved portion of the handpiece 103 that encompassesthe piston 110 and spring 111 actuation mechanism, followed by a thirdproximal straight portion of the handpiece 104 that encompasses anassortment of functional pipes 105.

FIG. 2 shows a cross-section through the third portion of the handpiece104 illustrating how four functional pipes (105 collectively) may fittogether in a linear array and how the periphery of the second portionof the handpiece 103 has a variable size and shape for improvedergonomic handling, a better fit of the internal components (i.e.actuation mechanism) it holds, and a smoother interaction with bodytissue in the event it is necessary to insert the instrument deeplyenough that portion 103 actually enters the body. Any number offunctional pipes 105 having any number of functions can be provided solong as the pipes fit neatly together within the housing and aresecurely sealed and insulated to prevent leakage or safety issues. Thepipes 105 need not be arranged linearly but could also be staggered,arranged in a cross, arranged in a circle, etc. There may be four pipeswhich include (from left to right in FIG. 2): (i) a fiber optic cable orother means for visualizing 106 (including a source of recording such asa camera and/or a source of illumination such as a light); (ii) a powersource 107 (i.e. a pneumatic air supply that feeds a piston 110); (iii)an aspiration line 108 removing tissue that turns into the cutting blade123 distally and is geared to an actuation means (i.e. a piston 110);and an irrigating infusion line 109 that delivers coolants, nutrients,therapeutic agents, and/or water to flush and cleanse the coring site,draining distally through openings 119 in the light sheath 125 and cover101.

The infusion pipe carries an infusate, i.e., any infused materialincluding gases, liquids, and solids or mixed state dispersions. Theinfusate could be any number of materials including water, arefrigerated saline solution, or these materials including anantiseptic, anti-inflammatory, antibiotic, analgesic, or othertherapeutic agent dissolved or dispersed therein.

FIGS. 3-5 show how the internal components fit together within the first102, second 103, and third 104 portions of the handpiece. The light cone113 contains one or more indentations 114 that serve as a key hold forone or more corresponding protruding notches 128 on the inside of thehandpiece. The indentation 114 is shown in FIGS. 3-4 with the notch 128shown in FIG. 5. Three of the pipes including the infusion pipe 109, theaspiration pipe 108, and the fiber optic cable or light pipe 106 (leftto right in FIGS. 3-4) connect to and enter the light cone 113. Thepower supply pipe 107 does not enter the light cone but terminates atthe piston 110 to provide air pressure or another means for driving thepiston 110. A spring 111 on one side of the piston 110 provides thereturn force and a stroke stop 118 (see FIGS. 6-7) on the other side ofthe piston 110 maintains a space below/beside the piston face for theair pressure to work properly to be able to drive the piston.

The aspiration pipe 108 passes through the center of the piston 110 andis maintained in position by a means for stabilizing such as the distaland proximal O-rings 112. It is helpful for the aspiration pipe 108 tobe stabilized in some manner since the pipe 108 turns into the cuttingcore 124 and blade 123 at the instrument's distal working end. If theaspiration pipe 108 is not properly stabilized damage may result due toimprecision while the blade 123 interacts with tissue. The aspirationpipe 108 continues on to enter the light cone 113 through the base ofthe cone and to exit through the top of the cone where the aspirationpipe 108 becomes the cutting core 124 is surrounded by the light sheath125 and its opaque cover 101.

FIG. 5 shows how the handpiece can be segmented with the first portion102 (containing the light cone 113) divided from the second portion 103(containing the actuation means) and the third portion 104. FIG. 5 alsobetter illustrates how the power supply pipe 107 bends and passes lowinto a chamber in the second portion 103 to feed the piston 110. Theaspiration pipe 108 does not connect to the power supply pipe 107proximally (as it may appear at first glance) but rather, from the angleshown the power supply pipe 107 is directly over and obscuring theaspiration pipe 108 underneath it at the proximal end.

FIG. 6 shows just two of the pipes, the aspiration pipe 108 and fiberoptic cable 106 to more clearly show how the aspiration pipe 108 isgeared to the piston 110 with protruding extensions 116 on a wheelsurrounding the pipe mating with corresponding grooves 115 within thepiston 110 such that movement of the piston 110 turns the wheel andmoves the pipe 108 and the cutting core 124 on its distal end (see FIGS.10-11). FIG. 6 also shows a connector valve 117 through the base of thelight cone 113 for the infusion pipe 109 to deliver infusate to achamber 127 (see FIG. 13) in the light cone 113 for feeding the lightsheath 125.

FIG. 7 more clearly shows just the aspiration pipe 108 and itsinteraction with the piston 110 and spring 111.

FIGS. 8-12 show the cutting components at the distal end of theinstrument. FIGS. 8-9 show the cutting blade 123 within the protectivehood or dome 121 and the windows 122 therein through which the blade 123engages with tissue. There is a lens 120 at the distal end of the lightsheath 125 (125 as shown in FIGS. 13-16) and holes 119 extending throughboth the light sheath 125 and its opaque cover 101 for venting theinfusate which is conveyed through the extruded grooves 126 in the lightsheath 125 (see FIGS. 13-16).

FIGS. 10-11 show how the distal blade 123 is connected to a cutting core124. The cutting core 124 extends along the shaft and eventually turnsinto the aspiration pipe 108. FIG. 10 also shows how the curvature andgeometry of the blade 123 can be designed to correspond to the curvatureand geometry of the protective hooded dome 121 to cleanly slice tissuethrough the windows 122 upon impact.

FIG. 11 shows only the blade 123 and its integrated cutting core 124without the dome 121 while FIG. 12 shows only the hooded dome 121 andits cut-out windows 122 therein without the blade 123.

FIG. 13 shows how various ports connect within the light cone 113including how the aspiration pipe port 108 and infusion pipe port 109connect to a central chamber 127. Through the central chamber 127infusate is delivered distally to the target cutting zone (to exitthrough distal ports 119 as in FIG. 16) and severed tissue is suctionedproximally out of the device to be removed from the body. Infusate isconveyed by the light sheath 125 through extruded channels or grooves126 therein. One half of the light cone 113 may contain holes 129therein for connecting with protrusions in the other half. A fiber opticcable 106 or other visualization means feeding the light cone 113provides light to the target cutting zone at the distal end of theinstrument through the light sheath 125 that forms the periphery of thecutting core 124 in the distal region. An opaque cover 101 outside ofthe light sheath 125 prevents light from the fiber optic cable 106 fromdissipating through the transparent sheath 125 so that the lightactually reaches the distal end of the instrument to be concentrated andfocused onto the cutting elements (123, 122, 121) by the lens 120 at thedistal end of the light sheath 125.

FIG. 14 shows how the thin opaque cover 101 wraps around the lightsheath 125 and how the sheath 125 is capable of conveying infusate withthe extruded grooves 126 therein.

FIG. 15 shows how the elements of FIG. 14 connect with the light cone113 and how the light sheath 125 turns into the aspiration pipe 108within the light cone 113. The light sheath 125 begins covering theaspiration pipe 108 in the light cone 113 and is not needed over theaspiration pipe 108 at the proximal end of the instrument. FIG. 15 alsoshows how the connector valve 117 for the infusion pipe 109 feeds thechamber 127 and the grooves 126 in the light sheath 125.

FIG. 16 more clearly shows how the light sheath 125 turns into a lens120 at its distal end and how the holes 119 through the light sheath 125and opaque cover 101 permit ventilation of the infusate conductedthrough channels 126.

FIG. 17 shows the pertinent anatomy for the mechanical coring proceduredescribed herein. More specifically, the anterior prostate 200, medialprostate 202, and posterior prostate 204 are shown. The urethral canal210 extends up to the bladder 206 between the anterior prostate 200 andthe medial prostate 202. The seminal vesicle 208 is positioned betweenthe medial prostate 202 and the posterior prostate 204 and extendsaround the bladder and down to the testicles.

FIG. 18 shows an access tool 170 being inserted transperineally tocreate a small self-sealing micro puncture that provides access to thecore prostate tissue (to be removed) for the mechanical coring probe.

FIG. 19 shows the mechanical coring probe 150 being insertedtransperineally into the prostate through the small self-sealing micropuncture site with the assistance of a template or grid 160. Theguidance template or grid 160 can be used in conjunction with ultrasoundto direct accurate placement of the probe 150.

Following removal of core prostate tissue by the mechanical coring probe150, cavities 216, 218 are created in one or more prostate lobes 200,202, 204 or sections as shown in FIG. 20. For example, as shown, a firstcavity 216 may be created in the anterior prostate lobe 200 and a secondcavity 218 may be created in the posterior prostate lobe 204. A device260 may be inserted in a vicinity of the cavities to ensure hemostasis.For example, device 260 may be a microscopic end cauterizing probe ormay be used to deliver sealants, hemostatic agents, or coagulants,including a polyethylene glycol (PEG) plug.

When a transurethral approach is used for one or more steps of theprostate treatment procedure, the urethral canal 210 should first beprotected by introducing a pre-lubricated, inflatable, luminallyprotective sheath 240 as shown in FIG. 21A. The windows along the sheathprevent over-inflation to ensure that even after inflation instrumentscan still fit through the center of the sheath. FIG. 21B shows adelivery instrument 246 for introducing the protective sheath 240. FIG.22 shows the inflation device 250 for inflating the protective sheath240, shown mounted over the delivery instrument 246. The protectivesheath 240 may have measurement markers thereon as shown to assist asurgeon in determining how far up the urethral canal the sheath has beeninserted.

FIG. 23 shows the protective sheath 240 being inserted up the urethralcanal 210 in a deflated condition. Also shown are the sealants 175 whichmay have been delivered by hemostat delivery device 260. Sealants 175ensure hemostasis is maintained near the openings to the cavities 216,218 where prostate tissue has been removed. These sealants may includeany hemostatic agents known in the art. A preferred sealant is apolyethylene glycol (PEG) plug 177.

FIG. 24 shows the protective sheath 240 advanced farther up the urethralcanal 210 and after inflation. In FIG. 25, a tamponading balloon 220, indeflated condition, is also shown being advanced up the urethral canalthrough the inflated protective sheath 240.

FIG. 26A shows the dual tamponading balloons 220, 222 in deflatedcondition being advanced further, beyond the end of the protectivesheath 240. A first tamponading balloon 220 is between the anteriorprostate lobe 200 and the medial prostate lobe 202 and between theurethral canal 210 and the bladder 206. A second tamponading balloon 222is between the medial prostate lobe 202 and the posterior prostate lobe204 within the seminal vesicle 208.

FIG. 26B shows the inflation apparatus 224 for the dual tamponadingballoon prostaplasty system. Two inflation ports 230, 232 are providedso that both balloons 220, 222 can be inflated simultaneously to evenlyapply pressure and induce hemostasis in the prostate lobes. A pressuregauge 228 is provided on the inflation apparatus 224 to prevent overinflation of the tamponading balloons 220, 222. The tamponading balloons220, 222 are preferably injected with a unit dose of refrigerated orcooled saline solution 236 in a disposable vial that can be mounted ontoa loading port 226 of the inflation apparatus 224. A plunger 234 may beused to initiate inflation.

FIG. 27 shows the tamponading balloons 220, 222 after inflation,illustrating how they apply pressure to the prostate lobes 200, 202, 204on either side of them while enlarging the channels, 210 to 206 and 208,between the lobes. FIG. 28 shows the enlarged channels, 210 to 206 and208, of the urethral canal 210 and the seminal vesicle 208 after thetamponading balloons 220, 222 have been deflated and removed.

FIG. 29 shows the surgical console 270 including ports 298 on the sidefor connection to an audio/video system. The console 270 houses anidentification-sensitive seal-sealed surgical cassette 280 that collectsremoved tissue. Flexible tubing lines 294 having pinch valves 296thereon extend from the console to the mechanical coring probe 150 andto a fluid source for irrigation. A foot pedal 292 is electricallyconnected to the console 270 through a cord 290. The foot pedal can beused to control the rate of coring and aspiration. Through the consolevarious features can be adjusted including illumination, atherectomyspeed, and the like as shown by the displays and buttons. One or morepumps 291 may be provided within the console for driving aspiration. Forexample, the pump 291 may be of the peristaltic type activated uponappropriate connection of the identification-sensitive self-sealedcassette 280.

Closing Comments

Throughout this description, the embodiments and examples shown shouldbe considered as exemplars, rather than limitations on the apparatus andprocedures disclosed or claimed. Although many of the examples presentedherein involve specific combinations of method acts or system elements,it should be understood that those acts and those elements may becombined in other ways to accomplish the same objectives. With regard toflowcharts, additional and fewer steps may be taken, and the steps asshown may be combined or further refined to achieve the methodsdescribed herein. Acts, elements and features discussed only inconnection with one embodiment are not intended to be excluded from asimilar role in other embodiments.

As used herein, “plurality” means two or more. As used herein, a “set”of items may include one or more of such items. As used herein, whetherin the written description or the claims, the terms “comprising”,“including”, “carrying”, “having”, “containing”, “involving”, and thelike are to be understood to be open-ended, i.e., to mean including butnot limited to. Only the transitional phrases “consisting of” and“consisting essentially of”, respectively, are closed or semi-closedtransitional phrases with respect to claims. Use of ordinal terms suchas “first”, “second”, “third”, etc., in the claims to modify a claimelement does not by itself connote any priority, precedence, or order ofone claim element over another or the temporal order in which acts of amethod are performed, but are used merely as labels to distinguish oneclaim element having a certain name from another element having a samename (but for use of the ordinal term) to distinguish the claimelements. As used herein, “and/or” means that the listed items arealternatives, but the alternatives also include any combination of thelisted items.

It is claimed:
 1. A probe configured for insertion through a skin into atissue for mechanically cutting comprising: a cutting core disposed in ahousing, the cutting core having at least one sharp curved edge locatedin a distal region of the cutting core for cutting, the cutting corealso having a channel formed therein for providing aspiration of fluidand bodily material while the sharp curved edge is cutting, the cuttingcore adapted for variable actuation including continuous activation andpulsed activation; the housing disposed around the cutting core, thehousing having one or more openings or portals in a distal regionthereof, at least one opening or portal being at least partially open atall times during the aspiration of fluid and bodily material; ahandpiece on an outside of a proximal end of the probe, the handpiecedisposed around and receiving the cutting core and the housing; a coverdisposed at and covering a distal region of the handpiece, wherein theaspiration channel of the cutting core and the housing are received byand extend distally from the cover, the cover having a chamber therein;an aspiration pipe, defined as a proximal portion of the cutting corewithin the handpiece, the aspiration pipe received by and extendingproximally from the cover; a movable member in the handpiece configuredto drive the cutting core; and a pneumatic air supply pipe in thehandpiece configured to supply air to displace the movable member anddrive the cutting core.
 2. The probe of claim 1 wherein the movablemember is a piston disposed around the aspiration pipe and configuredfor driving the cutting core, a second end of the piston having a strokestop, wherein the stroke stop is configured for maintaining a space forair pressure to drive the piston and the pneumatic air supply pipeterminates at the space.
 3. The probe of claim 2 wherein a first end ofthe piston opposite the second end has a spring configured for providinga return force to the piston.
 4. The probe of claim 1 further comprisinga plurality of pipes disposed within the handpiece, at least one of theplurality of pipes received by and extending proximally from the cover.5. The probe of claim 4 the plurality of pipes including a visualizationpipe, an infusion pipe, and an aspiration pipe; each of thevisualization pipe, the infusion pipe, and the aspiration pipe connectto and enter an intermediate member having ports at a distal end of thehandpiece that in turn is in communication with and extends proximallyfrom the cover; wherein the infusion pipe is configured to deliver fluidto the chamber of the cover.
 6. The probe of claim 5 wherein the cuttingcore is a portion of the aspiration pipe distal to the cover.
 7. Theprobe of claim 5, the cover having at least one indentation on a surfacethereof configured to mate with a corresponding protrusion on an innersurface of the handpiece to hold the cover in position within thehandpiece.
 8. The probe of claim 1 including a sealing device forsimultaneously tamponading, inducing hemostasis, and dilating aplurality of lumens.
 9. The probe of claim 8 wherein the sealing deviceincludes a plurality of tamponading balloons configured for inflationwith a coolant fluid.
 10. The probe of claim 1 further comprising aplurality of fluid pathways configured for conducting fluid towards adistal end of the housing while the channel of the cutting core isproviding aspiration.
 11. A probe configured for insertion through askin into a tissue for mechanically cutting comprising: a cutting coredisposed in a housing, the cutting core having at least one sharp curvededge located in a distal region of the cutting core for cutting, thecutting core also having a channel formed therein for providingaspiration of fluid and bodily material while the sharp curved edge iscutting; the housing disposed around the cutting core, the housinghaving one or more openings or portals in a distal region thereof, atleast one opening or portal being at least partially open at all timesduring the aspiration of fluid and bodily material; a handpiece on anoutside of a proximal end of the probe, the handpiece disposed aroundand receiving the cutting core and the housing; a cover disposed at andcovering a distal region of the handpiece within an inner surface of thehandpiece, wherein the aspiration channel of the cutting core and thehousing are received by and extend distally from the cover, the coverhaving a chamber therein; an aspiration pipe, defined as a proximalportion of the cutting core within the handpiece, the aspiration pipereceived by and extending proximally from the cover; and a pistondisposed around the aspiration pipe and configured for driving thecutting core, a first end of the piston having a spring and a second endof the piston having a stroke stop, wherein the spring is configured forproviding a return force and the stroke stop is configured formaintaining a space for air pressure to drive the piston.
 12. The probeof claim 11 further comprising a pneumatic air supply pipe within thehandpiece and terminating at the space maintained by the stroke stop forair pressure to drive the piston, the pneumatic air supply pipeconfigured to supply air to drive the piston.
 13. The probe of claim 12wherein the piston is mounted to reciprocate transverse to alongitudinal axis of the handpiece, and is operatively connected torotate the cutting core about the longitudinal axis.
 14. The probe ofclaim 11 further comprising a plurality of pipes disposed within thehandpiece, at least one of the plurality of pipes received by andextending proximally from the cover.
 15. The probe of claim 14 theplurality of pipes including a visualization pipe, an infusion pipe, andan aspiration pipe; each of the visualization pipe, the infusion pipe,and the aspiration pipe connect to and enter an intermediate memberhaving ports at a distal end of the handpiece that in turn is incommunication with and extends proximally from the cover; wherein theinfusion pipe is configured to deliver fluid to the chamber of thecover.
 16. The probe of claim 15 wherein the cutting core is a portionof the aspiration pipe distal to the cover.
 17. The probe of claim 15,the cover having at least one indentation on a surface thereofconfigured to mate with a corresponding protrusion on an inner surfaceof the handpiece to hold the cover in position within the handpiece. 18.The probe of claim 11 including a sealing device for simultaneouslytamponading, inducing hemostasis, and dilating a plurality of lumens.19. The probe of claim 18 wherein the sealing device includes aplurality of tamponading balloons configured for inflation with acoolant fluid.
 20. The probe of claim 11 further comprising a pluralityof fluid pathways configured for conducting fluid towards a distal endof the housing while the channel of the cutting core is providingaspiration.